Events

Recall of Device Recall N acetylprocainamide reagent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Diagnostics Operations, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    54624
  • Event Risk Class
    Class 2
  • Event Number
    Z-2386-2010
  • Event Initiated Date
    2010-02-05
  • Event Date Posted
    2010-09-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88804
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Analyzer, enzyme, for clinical use - Product Code LAN
  • Reason
    The n-acetylprocainamide reagent lot 14456200 shows an incorrect expiration date of 7/31/2011. the correct expiration date for the lot is 1/31/2011.
  • Action
    Roche issued an "Urgent Medical Device Removal" letter dated February 2010 to consignees identifying the issue and affected product. Customers were requested to complete the attached form and return in to the firm to obtain replacement product. After receipt of replacement reagent, the customer should discard the affected product product. If unaffected lots are not available, customers may use the affected lot until replacement product is received. Use of the affected product before the corrected expiration date of January 31, 2011 should not produce erroneous test results. Roche Diagnostics Technical Support can be contacted at 1-800-428-2336.

Device

Device Recall N acetylprocainamide reagent

Manufacturer

Roche Diagnostics Operations, Inc.
  • Manufacturer Address
    Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis IN 46256
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    USFDA